Hästbacka Johanna, Westhall Erik, Moseby-Knappe Marion, Tiainen Marjaana, Lybeck Anna, Reinikainen Matti, Levin Helena, Skrifvars Markus B, Tirkkonen Joonas, Jakobsen Janus C, Nielsen Niklas, Toppila Jussi, Admiraal Marjolein M, Kortelainen Jukka
Department of Intensive Care, Faculty of Medicine and Health Technology, Tampere University Hospital, Wellbeing Services County of Pirkanmaa and Tampere University, Tampere, Finland.
Department of Clinical Sciences Lund, Lund University, Lund, Sweden.
Acta Anaesthesiol Scand. 2025 Oct;69(9):e70126. doi: 10.1111/aas.70126.
Early restitution of electroencephalogram (EEG) slow wave activity (SWA) may be able to predict favorable functional outcome after cardiac arrest. SWA can be monitored using the C-Trend Index, a recently developed dynamic numerical index computed using commercially available medical device software.
This is a pre-planned prospective substudy of the randomized controlled Sedation, TEmperature and Pressure after Cardiac Arrest and REsuscitation (STEPCARE) trial. With a factorial design, the STEPCARE trial evaluates the effects of three different interventions (sedation, temperature management, and mean arterial blood pressure) on functional outcomes in adult out-of-hospital cardiac arrest (OHCA) patients. We will record continuous EEG (cEEG) starting as early as possible after ICU admission. We will compare the accuracy (the proportion of correct predictions of all predictions) of C-Trend Index with that of blinded retrospective visual analysis of cEEG at 12 h after return of spontaneous circulation in predicting favorable functional outcome (modified Rankin Scale 0-3) 6 months after cardiac arrest. We aim to recruit 300 patients to show noninferiority in prognostic accuracy of the C-Trend Index compared with the visual analysis of cEEG, using a 2% limit for noninferiority. Furthermore, we will assess whether the therapeutic intervention related to sedation, carried out as a part of the STEPCARE trial modifies the performance of the EEG-based predictors.
The study will compare the accuracy of SWA measured using C-Trend Index with the gold standard, visual analysis of cEEG, in predicting favorable functional outcome after OHCA. The study will also assess the effect of the sedation intervention of the STEPCARE trial on the predictive accuracy of C-Trend Index. If the accuracy of the C-Trend Index is non-inferior to the comparator's, it may provide a feasible and easy-to-learn bedside method, especially in hospitals with limited availability of neurophysiology expertise.
ClinicalTrials.gov identifier: NCT06564675.
脑电图（EEG）慢波活动（SWA）的早期恢复可能能够预测心脏骤停后良好的功能结局。SWA可使用C趋势指数进行监测，C趋势指数是一种最近开发的动态数值指数，通过商用医疗设备软件计算得出。
这是一项预先计划的前瞻性亚研究，来自随机对照的心脏骤停与复苏后镇静、体温与血压（STEPCARE）试验。采用析因设计，STEPCARE试验评估三种不同干预措施（镇静、体温管理和平均动脉血压）对成年院外心脏骤停（OHCA）患者功能结局的影响。我们将在重症监护病房（ICU）入院后尽早开始记录连续脑电图（cEEG）。我们将比较C趋势指数与在自主循环恢复后12小时对cEEG进行盲法回顾性视觉分析在预测心脏骤停后6个月良好功能结局（改良Rankin量表0 - 3分）方面的准确性（所有预测中正确预测的比例）。我们旨在招募300名患者，以显示C趋势指数在预后准确性方面不劣于cEEG视觉分析，非劣效性界限设定为2%。此外，我们将评估作为STEPCARE试验一部分进行的与镇静相关的治疗干预是否会改变基于脑电图的预测指标的性能。
本研究将比较使用C趋势指数测量的SWA与金标准（cEEG视觉分析）在预测OHCA后良好功能结局方面的准确性。该研究还将评估STEPCARE试验的镇静干预对C趋势指数预测准确性的影响。如果C趋势指数的准确性不劣于对照方法，它可能提供一种可行且易于掌握的床边方法，尤其是在神经生理学专业知识有限的医院。
ClinicalTrials.gov标识符：NCT06564675
